SME Lab Auditing & Consulting provides specialized regulatory, quality, and laboratory compliance services for organizations operating in highly regulated environments. We support pharmaceutical manufacturers, medical device companies, testing laboratories, contract labs, and growing life science organizations seeking regulatory confidence and operational control.
Our consulting services are designed to reduce risk, strengthen quality systems, and ensure inspection readiness across FDA, ISO, and international regulatory frameworks.
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We support compliance with 21 CFR Parts 210 & 211 (Drug cGMP), 21 CFR Part 820 (Medical Devices – QSR), 21 CFR Part 11 (Electronic Records & Signatures), and 21 CFR Part 58 (GLP).
Structured evaluations to identify compliance gaps against applicable regulations and prioritize corrective actions.
Assessment of quality management systems and laboratory operations to strengthen controls and readiness.
Reviews to strengthen ALCOA+ and electronic records and signatures compliance under 21 CFR Part 11.
Support to improve corrective and preventive action systems and ensure robust root cause analysis and effectiveness.
Simulated FDA inspections to test readiness, staff knowledge, and document retrieval before real agency visits.
Planning and strategy for managing inspections, responses, and follow-up to demonstrate defensible systems.
Our approach ensures your organization demonstrates control, accountability, and defensible systems under regulatory scrutiny.
We provide practical, operational compliance support across Good Manufacturing Practice, Good Laboratory Practice, and Good Clinical Practice (laboratory support).
Focus: QC laboratories, manufacturing support labs, biotechnology, and API facilities. Support includes validated methods, equipment qualification, documentation control, deviation and OOS management, and ALCOA+ data integrity compliance.
Focus: Non-clinical research, toxicology, safety, and preclinical studies. Support includes study integrity, QA unit oversight, raw data traceability, and archival systems.
Focus: Clinical trial laboratory operations. Support includes sample chain of custody, bioanalytical validation, and regulatory data reliability.
We guide laboratories through accreditation readiness and long-term compliance.
Gap assessments against ISO/IEC 17025 requirements.
QMS development and documentation, method validation and verification, and measurement uncertainty and traceability programs.
Internal audits and management review support, and mock accreditation assessments.
We help laboratories achieve and maintain accreditation with confidence.
A structured evaluation comparing your current systems against applicable regulations or standards. Deliverables include a detailed risk-ranked report and corrective action roadmap.
Mock inspections and audit simulations to test real-world preparedness, staff knowledge, and document retrieval capability.
We prepare organizations for FDA inspections, ISO certification and surveillance audits, and accreditation body assessments.
Services include mock inspections, staff coaching, documentation review, and inspection management strategy development.
We provide structured response support for:
Services include root cause analysis, CAPA development, response drafting, timeline management, and follow-up.
For organizations seeking broader quality system alignment, we provide ISO 9001 gap analysis, QMS design and process standardization, risk-based thinking implementation, internal audit programs, and certification readiness support. Our goal is to create efficient, integrated systems that align regulatory, accreditation, and business objectives.
Independent and third-party audits designed to identify risk and strengthen compliance.
Internal laboratory audits (GMP, GLP, ISO 17025), external and supplier audits, and third-party contract laboratory audits.
Method validation and transfer audits, data integrity and ALCOA+ compliance audits, and QMS integration audits.
Pre-accreditation audits and mock regulatory inspections to test real-world preparedness.
Our audits are objective, risk-focused, and designed to strengthen both compliance and operational performance.